Douglas L. Mayers, M.D., EVP and Chief Medical Officer, commented on the IDX-719 program and the next data presentation. He stated, "We look forward to data from higher doses as well as the initiation of a 3 day proof-of-concept study in treatment nieve genotype 1 HCV infected patients in the second quarter of 2012. We will also add cohorts of genotype 2,3 or 4 HCv infected patients during the 3 day segment of the study."
Source: Q4 2012 earnings conference call, 2/23/12.
In January 2012, the Company initiated a phase I clinical study of IDX719, its NS5A inhibitor candidate. The first part of the study is evaluating the safety, pharmacokinetics and food effect of IDX719 in 48 healthy volunteers at single doses ranging from 5 to 100 mg. Dosing up to 50 mg has been completed in healthy volunteers and to date IDX719 has been well tolerated. A cohort of eight HCV genotype 1-infected patients received single doses of IDX719 of either 1, 5, 10 or 25 mg (2 patients per dose). Mean maximal viral load reductions were 1.9 log(10), 2.6 log(10), 3.3 log(10) and 3.7 log(10), respectively. A 3-day proof-of-concept segment of the study in treatment-naive genotype 1 HCV-infected patients is expected to begin in the second quarter of 2012 with additional cohorts of genotype 2, 3, or 4 HCV-infected patients to be added during the study.
Source: press release, 2/23/12. http://ir.idenix.com/releasedetail.cfm?ReleaseID=651194
A Phase I/IIa Study Assessing Single and Multiple Doses of HCV NS5A Inhibitor IDX719 in Healthy and HCV-Infected Subjects
Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01508156?term=idenix&rank=5
|IDX-719||Infectious Disease||Hepatitis C infection (HCV) (non-responder patients)||HCV NS5a protein inhibitor||HCV NS5a protein|
Mechanism of action: IDX-719 is a novel HCV non-structural 5A (NS5A) protein inhibitor.
Phase of Development: Ib
Event Type: Data: Phase Ib trial results
Dates: 2012-04-01 - 2012-06-29
April 19, 2012
Idenix Pharmaceuticals Provides Update on Hepatitis C Clinical Development Programs
IDX719 Demonstrates Pan-Genotypic Activity at Single Doses in HCV-Infected Patients Achieving Greater Than 3 log10 Viral Load Reductions in the 100 mg Dose Group Across Genotypes 1, 2 and 3; Three-Day Proof-of-Concept Study Underway
IDX184/PegIFN/RBV Phase IIb Study Fully Enrolled
CAMBRIDGE, Mass., April 19, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced data from a phase I clinical trial of IDX719, an NS5A inhibitor for the treatment of hepatitis C virus (HCV) infection, demonstrating potent pan-genotypic antiviral activity with single doses.
In January 2012, Idenix initiated a phase I clinical study of IDX719. The first part of the study evaluated the safety, pharmacokinetics and food effect of IDX719 in 40 healthy volunteers at single doses ranging from 5 to 100 mg. Eight healthy volunteers received 100 mg of IDX719 daily for seven days. All doses were well tolerated and pharmacokinetic data supports once-daily dosing in future studies. In the second part of the phase I study, single-ascending doses of IDX719 achieved substantial viral load reductions in the following cohorts of HCV-infected patients:
A cohort of 12 HCV genotype 1-infected patients received single IDX719 doses of 1, 5, 10, 25, 50 or 100 mg (2 patients per dose). Mean maximal viral load reductions were 1.9 log10, 2.6 log10, 3.3 log10, 3.7 log10, 2.8 log10 and 3.5 log10, respectively;
A cohort of three HCV genotype 2-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 0.4 log10, 3.2 log10 and 3.5 log10, respectively; and
A cohort of three HCV genotype 3-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 2.2 log10, 3.7 log10 and 3.3 log10, respectively.
The single-dose data were presented at the Cambridge Healthtech Institute's 5th Annual HCV Drug Discovery meeting this week in San Diego, California. A three-day proof-of-concept study has initiated dosing and is designed to evaluate 64 treatment-naïve genotype 1, 2, 3 or 4 HCV-infected patients.
"These single-dose IDX719 data show potent viral load reductions, with some patients maintaining viral suppression out to three days," said Douglas Mayers, Chief Medical Officer of Idenix Pharmaceuticals. "We are pleased with the promising antiviral activity in genotypes 1, 2 and 3, and we look forward to seeing multiple-dose data in a larger number of patients from the ongoing three-day proof-of-concept study."
Source: press release, 4/19/12. http://ir.idenix.com/releasedetail.cfm?ReleaseID=665569